Associate Medical Director, Clinical Science, NS TAU

Job Description Associate Medical Director in Neuroscience Therapeutic Area Unit at Takeda, Cambridge, MA. This role drives the clinical development of assigned Takeda pipeline compound(s), leading strategy, decision-making, and collaboration with multi-regional, multi-disciplinary teams. Position Objectives The Associate Medical Director leads and drives strategy for clinical studies within the overall global clinical development for the assigned Takeda pipeline compound(s). Leads or joins multi-disciplinary, multi-regional, matrix teams through complex decisions, assessing and integrating input from various disciplines to create, maintain, and execute studies within a clinical development plan that will result in regulatory approval of the compound in multiple regions. Applies clinical/medical decision making to clinical development issues. Interacts with and influences Neuroscience Therapeutic Area Unit senior leadership decision-making by contributing to strategic direction. Success or failure directly translates to the ability of R&D to meet corporate goals for future commercial products. Accountabilities Represents Clinical Science on Study Execution and Clinical Teams and may serve as co-leader of these teams. Supports the Global Project Team to ensure that clinical team activities are aligned with the global strategy. May act as Global Clinical Lead for an early clinical stage or preclinical program with significant interactions with translational and biomarker colleagues, and preclinical teams. Contributes to Global Project and clinical team strategy and deliverables working on the Asset Strategy, Clinical Development Plan, Clinical Protocols and other documents needed for study execution. Recommends scope, complexity and size, influences the budget and makes high impact global decisions. Responsible for monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that influence regional and global development such as “go/no go” decisions or modification of development plans or study designs. Oversees all Clinical Science activities relating to preparation/approval of Synopses, Protocols and conduct of clinical studies. Interprets data from a scientific standpoint as well as within the context of medical significance to individual patients and presents study conclusions to Management. Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance and oversees non‑medical clinical scientists. Directs interactions with key opinion leaders relevant to assigned compounds and therapeutic area, leading negotiations and incorporating advice into study design. Responsible for evaluation of potential business development opportunities, due diligence, and negotiation of clinical development plans for potential alliances. Interacts with research division and other functions based on clinical and development expertise to provide knowledge and understanding of the market environment. Represents clinical science and contributes to or leads internal task forces and therapeutic area internal teams. Mentors, motivates, empowers, develops and retains staff. Education, Experience, Knowledge and Skills MD, MD/PhD, or internationally recognized equivalent plus 3 years of clinical research experience within the pharmaceutical industry, CRO, health‑related consulting, or biomedical/clinical academia. Previous experience successfully leading matrix teams. Previous experience in designing and executing first‑in‑human and early proof‑of‑concept trials. Superior communication, strategic, interpersonal and negotiating skills. Ability to proactively predict issues and solve problems. Ability to drive decision‑making within a multi‑disciplinary, multi‑regional, matrix team. Diplomacy and positive influencing abilities. Neurology therapeutic area knowledge (preferred). Specialization in Neurology, neuromuscular disease or neurodegenerative disease (preferred). Knowledge of regional/global regulatory requirements and GCP/ICH. Travel Requirements Ability to drive or fly to meetings or client sites, including overnight trips. Some international travel may be required. Approximately 10–20% travel. Location United States – Massachusetts – Cambridge. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. #J-18808-Ljbffr